Effects of TEAS on Stress Response During Extubation of General Anesthesia in Elderly Patients

Stress Clinical Trial

Official title:

Effects of Transcutaneous Electrical Acupoint Stimulation on the Stress Response During Extubation After General Anesthesia in Elderly Patients Undergoing Elective Supratentorial Craniotomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02533388
• Other study ID #: TEAS on stress
• Status: Completed
• Phase: N/A
• First received: June 4, 2015
• Last updated: March 10, 2017
• Start date: December 2015
• Est. completion date: March 2017

Study information

• Verified date: March 2017
• Source: Shengjing Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Elderly patients have an increased risk of stress responses during extubation after general anaesthesia for an elective supratentorial craniotomy. How to decrease the stress responses during extubation after general anaesthesia remains challenging for the anaesthesiologist. In this study, we aimed to investigate whether transcutaneous electrical acupoint stimulation (TEAS) might decrease the stress responses and improve the quality of recovery in the elderly patients who underwent elective supratentorial craniotomy under general anaesthesia.

Description:

A total of 100 elderly patients scheduled for elective supratentorial craniotomy under propofol-remifentanil total intravenous anaesthesia were randomly divided to either TEAS group (received stimulation at LI4, PC6, LU7, LU5, LI18 and ST9 acupoints, 2/10Hz, 6-15 mA) or Sham group (received no stimulation). The primary outcomes were the haemodynamic parameters and plasma concentrations of epinephrine (E), norepinephrine (NE) and cortisol (Cor). The secondary outcomes were the consumption of remifentanil and propofol, the time from discontinuation of anesthetics to extubation and reorientation, extubation quality score, the quality of postoperative recovery and postoperative complications.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 70 Years

Eligibility

Inclusion Criteria:

• ASA ?~?

• aged 60—70years

• scheduled for elective supratentorial craniotomy under general anaesthesia

Exclusion Criteria:

• past or current history of cardiovascular and/or cerebrovascular diseases

• diabetes

• pre-existing liver, lung or kidney dysfunction

• psychiatric disorders

• potentially difficult airway

• previous acupuncture treatment

• infection at the stimulus sites

Related Conditions & MeSH terms

• Stress

Intervention

Device:
• Hwato Electronic Acupuncture Treatment Instrument
Thirty minutes prior to the induction of anaesthesia, the patients in the TEAS group started to receive TEAS by a stimulator (Hwato Electronic Acupuncture Treatment Instrument, model No.: SDZ-II, Suzhou Medical Appliances Co., Ltd., Suzhou, China) to the right hand, forearm and neck by an experienced acupuncturist at the Hegu (LI4), Neiguan (PC6), Lieque (LU7), Chize (LU5), Futu (LI18) and Renying (ST9) acupoints. TEAS was peformed with an alternate dense-disperse frequency of 2 and10 Hz ( 2 Hz for 10 s and 10 Hz for 5 s). The optimal intensity ranged from 6-15 mA, The stimulus continued until 5 min before the end of surgery.
• Placebo
The patients in the Sham group were also connected to the apparatus, but electronic stimulation was not applied.

Locations

Country	Name	City	State
China	Shengjing hospital of China medical university	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
Shengjing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Non-invasive arterial blood pressure	Non-invasive arterial blood pressure was recorded before the onset of TEAS,prior to induction, at the end of surgery, immediately after extubation, and 5 and 10 min after extubation	Before the onset of TEAS,prior to induction, at the end of surgery, immediately after extubation, and 5 and 10 min after extubation
Primary	Change in plasma concentrations of epinephrine	plasma concentrations of epinephrine was recorded before the onset of TEAS,prior to induction, at the end of surgery, immediately after extubation, and 5 and 10 min after extubation	Before the onset of TEAS,prior to induction, at the end of surgery, immediately after extubation, and 5 and 10 min after extubation
Primary	Change in mean arterial blood pressure	Mean arterial blood pressure was recorded before the onset of TEAS,prior to induction, at the end of surgery, immediately after extubation, and 5 and 10 min after extubation	Before the onset of TEAS,prior to induction, at the end of surgery, immediately after extubation, and 5 and 10 min after extubation
Primary	Change in heart rate	Heart rate was recorded before the onset of TEAS,prior to induction, at the end of surgery, immediately after extubation, and 5 and 10 min after extubation	Before the onset of TEAS,prior to induction, at the end of surgery, immediately after extubation, and 5 and 10 min after extubation
Primary	Change in norepinephrine	Norepinephrine was recorded before the onset of TEAS,prior to induction, at the end of surgery, immediately after extubation, and 5 and 10 min after extubation	Before the onset of TEAS,prior to induction, at the end of surgery, immediately after extubation, and 5 and 10 min after extubation
Primary	Change in cortisol	Cortisol was recorded before the onset of TEAS,prior to induction, at the end of surgery, immediately after extubation, and 5 and 10 min after extubation	Before the onset of TEAS,prior to induction, at the end of surgery, immediately after extubation, and 5 and 10 min after extubation
Secondary	Postoperative quality of recovery assessed by Quality of Recovery-40 questionnaire(QoR-40)		From discontinuation of anaesthetic drugs to 24 h after surgery
Secondary	the time to extubation,the time to reorientation		From discontinuation of anaesthetic drugs to 24 h after surgery
Secondary	the quality of extubation was evaluated by a 5-point Extubation Quality Score		From discontinuation of anaesthetic drugs to 24 h after surgery
Secondary	The total amount of remifentanil that used throughout the surgery		From discontinuation of anaesthetic drugs to 24 h after surgery
Secondary	The total amount of propofol that used throughout the surgery		From discontinuation of anaesthetic drugs to 24 h after surgery
Secondary	Postoperative complications,like cough,agitation,nausea and vomiting	Cough was assessed using a four-point scale;Agitation was evaluated using the Ricker Sedation-Agitation Scale;Nausea was defined as the patient complained of an unpleasant sensation with the urgency to vomit. Vomiting was defined as the forceful expulsion of gastric contents from the patient's mouth.	From discontinuation of anaesthetic drugs to 24 h after surgery